Senior Biopharmaceutical Process Development Engineer

il y a 4 semaines


Toulouse, Occitanie, France Just Evotec Biologics EU Temps plein
About Just Evotec Biologics EU

Just Evotec Biologics EU is a leading biotech company that specializes in the development and manufacturing of biopharmaceuticals. With a strong focus on innovation and collaboration, we are seeking a highly motivated Senior Biopharmaceutical Process Development Engineer to join our team.

Estimated Salary: $120,000 - $180,000 per yearAbout the Role

The Senior Biopharmaceutical Process Development Engineer will play a key role in leading cross-functional teams to develop and implement new products for commercial GMP manufacturing activities. This includes collaborating with Product and Process Design, Process Engineering, Process Automation, Quality Controls, Quality Assurance, Supply Chain, Manufacturing, Digital, and EHS departments.

This role requires strong leadership capabilities to drive change and influence internal and external stakeholders. The ideal candidate will have a proven track record of accomplishment in GMP pharmaceutical or biotechnology, with a strong background in purification and solution preparation operations using disposable-based manufacturing technologies.

Key Responsibilities
  • Lead Downstream stakeholders NPI process at J.POD Toulouse to support the start and rapid scale-up of commercial GMP manufacturing activities.
  • Partner with Product and Process Design to coordinate successful efficient scale-up and transfer operations and ensure the successful integration of process knowledge into manufacturing operations.
  • Support Downstream Bill of Material development and demand planning for new products.
  • Conduct facility fit assessments and plans to support system updates needed for new product introduction.
  • Develop high-quality batch records, robust processes, and innovative technology solutions for new product introduction.
  • Implement process validation and comparability study activities leading to successful product registration.
Requirements
  • Masters degree in relevant field or related program with 5-10 years of pharmaceutical/biotech validation experience.
  • Experience with late-stage clinical and/or commercial biologics drug substance manufacturing programs.
  • Proven record of accomplishment in GMP pharmaceutical or biotechnology.
  • Strong background and technical mastery of purification and solution preparation operations using disposable-based manufacturing technologies.
  • Leadership capabilities to contribute to building a high-performing team.
  • Good interpersonal, team, and collaborative skills.
  • Good verbal and written communication skills in English; ability to interface with all levels of the organization.
Benefits

As a Senior Biopharmaceutical Process Development Engineer at Just Evotec Biologics EU, you can expect a competitive salary package, comprehensive benefits, and opportunities for professional growth and development.


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